Meeting to Present Work-In-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 1: Health Consequence Scoring for Feed Contaminants, 43488-43489 [E6-12266]

Download as PDF 43488 Federal Register / Vol. 71, No. 147 / Tuesday, August 1, 2006 / Notices year 2006 and scroll down to the above named committee meeting.) Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 13, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants and an indication of the approximate time requested to make their presentation on or before September 13, 2006. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact John Lauttman at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 18, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–12269 Filed 7–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N–0312] Meeting to Present Work-In-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 1: Health Consequence Scoring for Feed Contaminants AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. rwilkins on PROD1PC63 with NOTICES ACTION: SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting it will hold to present work-in-progress on a method for VerDate Aug<31>2005 20:04 Jul 31, 2006 Jkt 208001 ranking animal feed contaminants by their relative risks to animal and human health. The relative risk posed by feed contaminants to animal and human health consists of two components, namely health consequence scoring and exposure scoring. At this meeting the agency will describe the methods it plans to use to develop animal and human health consequence scoring for chemical, physical, and biological feed contaminants. At one or more subsequent public meetings, FDA will present information about how the health consequence scoring will be combined with information about the exposure of animals and humans to feed contaminants to determine the relative risks of such contaminants in feed. Date and Time: The public meeting will be held on September 12, 2006, from 9 a.m. to 4:30 p.m. Location: The meeting will be held at the Center for Drug Evaluation and Research Conference Room, third floor, 7519 Standish Pl., Rockville, MD 20855. ADDRESSES: You may submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments. FOR FURTHER INFORMATION CONTACT: Zoe Gill, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6867, FAX 240–453–6882, e-mail: zoe.gill@fda.hhs.gov. Registration: You may register by telephone, fax, or e-mail by contacting Nanette Milton, Center for Veterinary Medicine (HFV–200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6840, FAX 240–453–6880, e-mail: nanette.milton@fda.hhs.gov. Send registration information (including name, title, firm name, address, telephone, and fax number to Nanette Milton. To obtain the registration form via the Internet go to https:// www.fda.gov/cvm/AFSS.htm#Meetings. Due to limited meeting space, registration will be required. We strongly encourage early registration. SUPPLEMENTARY INFORMATION: I. Background The Animal Feed Safety System (AFSS) is FDA’s program for animal feed aimed at protecting human and animal health by ensuring animal feed is safe. It covers the entire spectrum of agency activities from preapproval of PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 food additives and drugs for use in feed, to establishing limits for feed contaminants, providing education and training, and conducting inspections and taking enforcement actions for ensuring compliance with agency regulations. AFSS includes oversight of all feed ingredients and mixed feed at all stages of manufacture, production, distribution, and use, whether at commercial or non-commercial establishments. During the past several years, FDA has been considering changes that need to be made to AFSS to ensure that it is comprehensive, preventive, and riskbased. As part of this effort, the agency is developing a model for ranking the relative risks to human and animal health of contaminants in animal feed. An effective model will permit the agency to systematically distinguish among feed hazards based on the relative risks they pose to animals or humans. Such a model will consider the risks of hazards present in incoming materials or feed ingredients and will also consider how activities at feed manufacturing, storage, distribution, and transportation facilities may modify such risks. For the purpose of AFSS, FDA defines a feed hazard as a biological, chemical, or physical agent in, or condition of, feed with the potential to cause an adverse health effect in animals or humans. Previously, FDA held two public meetings to discuss AFSS, including discussions of the agency’s plan to develop a risk ranking model for determining the relative risks to animal or human health of feed hazards. The first meeting was held on September 23 and 24, 2003, in Herndon, VA, and the second meeting was held on April 5 and 6, 2005, in Omaha, NE. The public meetings included active participation by consumers, animal feed processors, animal producers, and State and other Federal Government agencies. Following the meetings, we placed a number of documents in FDA’s docket for the AFSS project (found in brackets in the heading of this document). These documents included transcripts of the meetings, summaries of break-out discussion groups, presentations of invited speakers, and meeting summaries. We also placed in the docket a number of other documents relating to AFSS, including a framework for AFSS that lists the principal components of AFSS and the gaps the agency has identified which are being addressed by the agency team working on the AFSS project. These documents provide excellent, general background material on AFSS for the public meeting that will be held on September 12, 2006. E:\FR\FM\01AUN1.SGM 01AUN1 Federal Register / Vol. 71, No. 147 / Tuesday, August 1, 2006 / Notices This meeting is the first of several planned by FDA to discuss aspects of the AFSS relative risk ranking model during the model’s development by the agency. To determine the relative risks of chemical, physical, and biological contaminants in animal feed, information about the health consequences posed by the contaminant (represented by a health consequence scoring) is combined with information about the amount of the contaminant in animal feed (represented by an exposure scoring). This meeting will describe the methods used by the agency to develop the animal and human health consequence scoring for feed contaminants. At one or more subsequent meetings, FDA will present information about exposure of animals and humans to contaminants in feed and information about how health consequence scoring is combined with exposure scoring to determine the relative risks of contaminants in animal feed. II. Meeting We are holding the meeting in an effort to gather further information from you, our stakeholders, on changes to AFSS that will help minimize risks to animal and human health associated with animal feed. Prior to the public meeting, FDA will place in the docket (found in brackets in the heading of this document) two documents, entitled ‘‘List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients’’ and ‘‘Determining Health Consequence Scoring for Feed Contaminants.’’ The documents will summarize the agency’s methods for assigning animal and human health consequence scoring to physical, chemical, and biological contaminants that may be present in animal feed. Details of these methods will be discussed at the meeting. A draft agenda for the meeting will also be placed in the docket prior to the meeting. rwilkins on PROD1PC63 with NOTICES III. Comments If you would like to submit written comments to the docket, please send you comments to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two paper copies of any written comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. You can view comments FDA has VerDate Aug<31>2005 20:04 Jul 31, 2006 Jkt 208001 received on the Internet at https:// www.fda.gov/ohrms/dockets/. Dated: July 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–12266 Filed 7–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 6, 2006, from 8 a.m. to 5 p.m. and September 7, 2006, from 8 a.m. to 12 noon. Location: Hilton, Washington DC/ Silver Spring, Maryland Ballrooms, 8727 Colesville Rd., Silver Spring, MD. Contact Person: Johanna M. Clifford, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, email: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: On September 6, 2006, the committee will discuss two new drug applications (NDAs): (1) NDA 21–874, proposed trade name GENASENSE (oblimersen sodium) Injection, Genta, Inc., proposed indication for the treatment of patients with chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide; and (2) NDA 020– 287, FRAGMIN (dalteparin sodium), Pfizer, Inc., proposed indication for the extended treatment of symptomatic venous thromboembolism (VTE), proximal deep vein thrombosis, and/or pulmonary embolism to reduce the PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 43489 recurrence of VTE in patients with cancer. On September 7, 2006, the committee will discuss NDA 21–660, ABRAXANNE (paclitaxel protein-bound particles for injectible suspension) (albumin-bound), Abraxis Bioscience, Inc., including trial design issues for adjuvant treatment of node-positive breast cancer. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 22, 2006. Oral presentations from the public will be scheduled between approximately 10 a.m. to 10:30 a.m., and 2:30 p.m. to 3 p.m. on September 6, 2006, and between approximately 10 a.m. to 10:30 a.m. on September 7, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation before August 22, 2006. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Johanna Clifford at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 18, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–12270 Filed 7–31–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 71, Number 147 (Tuesday, August 1, 2006)]
[Notices]
[Pages 43488-43489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0312]


Meeting to Present Work-In-Progress on a Method for Ranking Feed 
Contaminants According to the Relative Risks They Pose to Animal and 
Public Health; Part 1: Health Consequence Scoring for Feed Contaminants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting it will hold to present work-in-progress on a method for 
ranking animal feed contaminants by their relative risks to animal and 
human health. The relative risk posed by feed contaminants to animal 
and human health consists of two components, namely health consequence 
scoring and exposure scoring. At this meeting the agency will describe 
the methods it plans to use to develop animal and human health 
consequence scoring for chemical, physical, and biological feed 
contaminants. At one or more subsequent public meetings, FDA will 
present information about how the health consequence scoring will be 
combined with information about the exposure of animals and humans to 
feed contaminants to determine the relative risks of such contaminants 
in feed.
    Date and Time: The public meeting will be held on September 12, 
2006, from 9 a.m. to 4:30 p.m.
    Location: The meeting will be held at the Center for Drug 
Evaluation and Research Conference Room, third floor, 7519 Standish 
Pl., Rockville, MD 20855.

ADDRESSES: You may submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. Follow the instructions for submitting 
comments.

FOR FURTHER INFORMATION CONTACT: Zoe Gill, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6867, FAX 240-453-6882, e-mail: 
zoe.gill@fda.hhs.gov.
    Registration: You may register by telephone, fax, or e-mail by 
contacting Nanette Milton, Center for Veterinary Medicine (HFV-200), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
240-453-6840, FAX 240-453-6880, e-mail: nanette.milton@fda.hhs.gov. 
Send registration information (including name, title, firm name, 
address, telephone, and fax number to Nanette Milton. To obtain the 
registration form via the Internet go to https://www.fda.gov/cvm/
AFSS.htm#Meetings. Due to limited meeting space, registration will be 
required. We strongly encourage early registration.

SUPPLEMENTARY INFORMATION:

I. Background

    The Animal Feed Safety System (AFSS) is FDA's program for animal 
feed aimed at protecting human and animal health by ensuring animal 
feed is safe. It covers the entire spectrum of agency activities from 
preapproval of food additives and drugs for use in feed, to 
establishing limits for feed contaminants, providing education and 
training, and conducting inspections and taking enforcement actions for 
ensuring compliance with agency regulations. AFSS includes oversight of 
all feed ingredients and mixed feed at all stages of manufacture, 
production, distribution, and use, whether at commercial or non-
commercial establishments.
    During the past several years, FDA has been considering changes 
that need to be made to AFSS to ensure that it is comprehensive, 
preventive, and risk-based. As part of this effort, the agency is 
developing a model for ranking the relative risks to human and animal 
health of contaminants in animal feed. An effective model will permit 
the agency to systematically distinguish among feed hazards based on 
the relative risks they pose to animals or humans. Such a model will 
consider the risks of hazards present in incoming materials or feed 
ingredients and will also consider how activities at feed 
manufacturing, storage, distribution, and transportation facilities may 
modify such risks. For the purpose of AFSS, FDA defines a feed hazard 
as a biological, chemical, or physical agent in, or condition of, feed 
with the potential to cause an adverse health effect in animals or 
humans.
    Previously, FDA held two public meetings to discuss AFSS, including 
discussions of the agency's plan to develop a risk ranking model for 
determining the relative risks to animal or human health of feed 
hazards. The first meeting was held on September 23 and 24, 2003, in 
Herndon, VA, and the second meeting was held on April 5 and 6, 2005, in 
Omaha, NE. The public meetings included active participation by 
consumers, animal feed processors, animal producers, and State and 
other Federal Government agencies. Following the meetings, we placed a 
number of documents in FDA's docket for the AFSS project (found in 
brackets in the heading of this document). These documents included 
transcripts of the meetings, summaries of break-out discussion groups, 
presentations of invited speakers, and meeting summaries. We also 
placed in the docket a number of other documents relating to AFSS, 
including a framework for AFSS that lists the principal components of 
AFSS and the gaps the agency has identified which are being addressed 
by the agency team working on the AFSS project. These documents provide 
excellent, general background material on AFSS for the public meeting 
that will be held on September 12, 2006.

[[Page 43489]]

    This meeting is the first of several planned by FDA to discuss 
aspects of the AFSS relative risk ranking model during the model's 
development by the agency. To determine the relative risks of chemical, 
physical, and biological contaminants in animal feed, information about 
the health consequences posed by the contaminant (represented by a 
health consequence scoring) is combined with information about the 
amount of the contaminant in animal feed (represented by an exposure 
scoring). This meeting will describe the methods used by the agency to 
develop the animal and human health consequence scoring for feed 
contaminants. At one or more subsequent meetings, FDA will present 
information about exposure of animals and humans to contaminants in 
feed and information about how health consequence scoring is combined 
with exposure scoring to determine the relative risks of contaminants 
in animal feed.

II. Meeting

    We are holding the meeting in an effort to gather further 
information from you, our stakeholders, on changes to AFSS that will 
help minimize risks to animal and human health associated with animal 
feed. Prior to the public meeting, FDA will place in the docket (found 
in brackets in the heading of this document) two documents, entitled 
``List of Potentially Hazardous Contaminants in Animal Feed and Feed 
Ingredients'' and ``Determining Health Consequence Scoring for Feed 
Contaminants.'' The documents will summarize the agency's methods for 
assigning animal and human health consequence scoring to physical, 
chemical, and biological contaminants that may be present in animal 
feed. Details of these methods will be discussed at the meeting. A 
draft agenda for the meeting will also be placed in the docket prior to 
the meeting.

III. Comments

    If you would like to submit written comments to the docket, please 
send you comments to the Division of Dockets Management (see 
ADDRESSES). Submit a single copy of electronic comments or two paper 
copies of any written comments, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. You can view comments FDA has received on the Internet 
at https://www.fda.gov/ohrms/dockets/.

    Dated: July 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12266 Filed 7-31-06; 8:45 am]
BILLING CODE 4160-01-S

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